Free eCTD Submission Checklist
Free Download
The Complete eCTD Submission Checklist
50+ validation checkpoints to ensure your regulatory submission is compliant with FDA, EMA, and ICH guidelines.
- Module-by-module validation steps
- Technical file format requirements
- FDA & EMA specific requirements
- Print-ready PDF format
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What's Inside the Checklist
Everything you need for a compliant submission
Document Structure
DTD versions, folder hierarchy, file naming, and PDF specifications for all modules.
Technical Validation
Checksum verification, hyperlink testing, file size limits, and virus scanning requirements.
Regional Requirements
FDA and EMA specific Module 1 requirements, forms, and labeling formats.
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